Identity
- Trade Name
- Niobe Cover Drape FDA UDI
- Generic Name
- Cardiac mapping system workstation FDA UDI
- Device Name
- Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction FDA UDI
Identifiers
- Catalog Number
- 001-005910-1 FDA UDI
- Primary DI / UDI-DI
- M58800100591011 FDA UDI
- 510(k) Number
- K060967 FDA UDI
- FDA Product Code
- NDQ FDA UDI
- GMDN Term
- Cardiac mapping system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1290 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Niobe Cover Drape by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060967 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA UDI d468506d-f52e-4479-9047-6b586a2bc2b4 38 fields · synced May 31, 2026